---
schema_version: "secwatch.filing_event.v1"
accession: "0001664710-25-000073"
form_type: "8-K"
ticker: "KROS"
cik: "0001664710"
company_name: "Keros Therapeutics, Inc."
filed_at: "2025-08-20T23:59:59+00:00"
generated_at: "2026-05-17T11:10:01.038902+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Keros receives FDA Orphan Drug designation for KER-065 in Duchenne muscular dystrophy

## Summary
- FDA granted Orphan Drug designation for KER-065, a TGF-ß family protein-targeting therapy for DMD.
- Designation provides potential 7-year market exclusivity, tax credits, and fee waivers if approved.
- KER-065 is advancing toward a Phase 2 clinical trial in patients with DMD, as stated by CEO.
- DMD affects fewer than 200,000 people in the U.S., qualifying for Orphan Drug status.
- Keros (KROS) is a clinical-stage biopharma focused on TGF-ß signaling disorders.

## SEC filing metadata
- accession: 0001664710-25-000073
- form_type: 8-K
- ticker: KROS
- cik: 0001664710
- company_name: Keros Therapeutics, Inc.
- filed_at: 2025-08-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1664710/000166471025000073/0001664710-25-000073-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1664710/000166471025000073/kros-20250820.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001664710-25-000073
- JSON: https://secwatch.observer/filing/0001664710-25-000073.json
- Plain text: https://secwatch.observer/filing/0001664710-25-000073.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.